Thursday, November 29, 2012

Medtronic says federal rules prohibit giving Ms. Hubbard's data to anyone but her doctor and hospital. "Our customers are physicians and hospitals," said Elizabeth Hoff, general manager of Medtronic's data business. Medtronic would need regulatory approval to give patients the data, she said. It hasn't sought approval because "we don't have this massive demand."

. . .

Some legal experts say the 1996 U.S. law governing patient access to their health files—HIPAA, or the Health Insurance Portability and Accountability Act—hasn't kept up with technology. The law gives patients the right to access information held by doctors and hospitals. However, the raw data gathered by an implant isn't held by a doctor or a hospital: Typically it goes directly to the device maker, which provides a summary report to the doctor. Because of this, the raw data falls outside the scope of HIPAA's patient-access requirements. In addition, Medtronic said, business agreements with doctors and hospitals restrict it to relaying information only to them.

"Is the device itself a depository for medical records?" said Paul C. Zei, a cardiologist at Stanford University Medical Center with a patient, Hugo Campos, who wants the same access to his cardiac-device data as the doctor gets. "Or is it part of the patient, and an extension of vital signs that we download into a medical chart?"

But as patients pay for more and more of their health care, companies better remember who's really their customer. Furthermore. patients should have access rights to all of their medical information, irrespective of where it resides.

Tuesday, November 27, 2012

Medical journals aren't what they used to be. Just ten short years ago, medical journals were places to report scientific study, interesting cases or clinical updates and reviews. They were, for the most part, about science and discovery.

Now, there is a dramatic shift of scientific content in our journals to politics and policy.

No where is this more evident than the much-heralded and widely read New England Journal of Medicine. (The Journal of the American Medical Association (JAMA) is not too far behind either.)

As an example, I was struck by this week's New England Journal of Medicine article titles:

I decided to look just 10 short years ago and compare what article titles existed in the New England Journal of Medicine from the week of November 21, 2002. Here are the article titles from that issue:

Perhaps the shift from science to politics in our major medical journals is an brief aberration, but I don't think so. I have noticed this phenomenon and expressed my concerns in 2006. The trend has only continued to grow: even our presidential candidates for the last election had postition papers published in the New England Journal of Medicine just before the election.

Seriously?

But the reality of politics and policy determining how medicine is practiced remains front-stage in medicine as cost and new structural concerns dominate health care. Medical questions, research and inquiry are increasingly second fiddle to health care political white papers. Adding to this lack of reporting of scientific discovery in major medical journals are the multiple rapid-fire, diverse portals for publication that exist for doctors and researchers these days thanks to the explosion of specialty publications and the Internet's impact on information delivery to doctors. As a result, there is a fierce media race underway to keep doctors eyes focused on these antiquated journals' content as doctors increasingly migrate away from print to electronic content.

If a major scientific journal like the New England Journal of Medicine decides to focus on policy instead of medicine, I suppose that's okay. That is their prerogative. But perhaps now that politics and policy have grown to such an extent in a major medical journal like the New England Journal of Medicine, the editorial board of this journal (and the others of similar political bents) should consider changing their name from the New England Journal of Medicine to the New England Journal of Perspectives.

At least then our young doctors of tomorrow will fully comprehend what they're getting.

This morning, a nice article in the Boston Globe appeared on Boston Scientific's subcutaneous implantable cardiac defibrillator (S-ICD) that recently received FDA approval. It was a fairly balanced article, one that touched ever-so-briefly on the pros and cons of a subcutaneous device to treat life-threatening cardiac arrhythmias using a medical device that does not require an internal wire inside the heart, but rather a sensing and shocking lead that is tunneled accross the chest under the skin (see my prior post on the details here).

But what I found most interesting in the article was the patient who was recommended for the device: a dialysis patient, was a patient who was specifically excluded from the FDA trials to approve the device (specifically, patients with GFR < 29 were excluded).

If you are a company that wants to get a device approved by the FDA, you want the best chances of having the fewest complications possible with new gadgets in medicine. Because sick dialysis patients have a way of having more complications with device implants, and the device companies know this, they are not included in trials to get a device approved.

Those of us who deal with ICDs in dialysis patients recognize the problems when ICD leads and dialysis catheters co-exist in the same vascular tree: the odds of infecting the ICD lead system is extraordinarily high. In fact, the overall mortality advantage of ICDs in dialysis patients is much less than patients not on dialysis. For this clinical circumstance, subcutaneous ICDs would seem to clearly be the better choice.

But dialysis patients are beset by another problem: challenges with potassium level regulation. Periods of hyperkalemia are quite common in dialysis patients and hyperkalemia commonly causes severe bradycardia. In these patients, pacing could maintain a patient's heart rate until their dialysis could be adjusted to lower their potassium and thereby improve their cardiac function. Subcutaneous ICDs do not have pacing capabilities, however.

So the reality of the effectiveness of the subcutaneous ICD to prolong life is uncertain in dialysis patients. This theory has never been tested - we just tend to think it makes intuitive sense to apply a new technology when other medical device choices are not perfect either.

The subcutaneous ICD FDA approval process is a good example of how clinical dogma spreads amongst doctors and patients without any proof of a device's effectiveness in some subselected patient populations. A new technology is approved by the FDA and receives a governmental stamp of approval. Doctors, then, serve as well-meaning spokespersons. The media gushes over the latest and greatest technology. And sales explode...

... all while some patients in whom the device is deployed doesn't realize the safety and efficancy of that device was never tested in their particular clinical circumstance.

We should remember that exclusion criteria in FDA clinical trials are important. They tell us who might and who might not benefit from a new technology. Too often we forget this.

Tuesday, November 20, 2012

I met her nearly thirty years ago: a older woman with a thick Bostonian accent. Opinionated. Forthright. Not afraid to share her thoughts. That’s the way it was. It was, after all, her house.

We met at the small wooden kitchen table that used the wall-hung telephone as its centerpiece and pierced the air with the loudest ring I’d ever heard. (I later learned her husband had been an infantryman in the Korean war who had heard his share of mortars.)

She had fixed dinner for the family – all of whom were arriving to meet her daughter’s new boyfriend: a small salad, ham, yellow mustard, mashed potatoes, and creamed onions.

The latter, I was to discover, was her personal favorite. Any gathering of family importance had them; the small iridescent pearls of tiny onions resting on cream-based sauce carefully created from a flour roux and can of the pearly whites. If it weren’t for her enthusiasm, I probably could have passed on them, but as it was, I had no choice but to place them on my plate. That’s the way she was.

A few Thanksgivings ago I sat with her, her eyes more sunken, her temples more defined. Her legs were thinner than I had remembered them just months before, and her voice was softer. Her graciousness, however, remained. She arrived bundled in her nicest jacket, her gait assisted by a quad cane and her husband’s gentle lift only a day after being discharged from the hospital. She smiled at the cacophony that greeted her. Folding chairs were pushed aside. She was led to a prime location to supervise the kitchen, a more stable chair arranged. The matriarch had arrived.

She saw that her son’s house was as hers had been this time of year: abuzz with activity and controlled chaos. Within the hustle and the bustle of meal preparation and family photos, came a phone call. Her daughter answered. Amongst the chatter a recipe was mentioned. It seems her granddaughter, unable to attend the local meal, had called to share a tradition involving small onions in her home. I saw the tiniest of smiles rise from her lips. For a brief moment the tumor didn’t matter, her pain forgotten as the recipe was recited.

Before long the meal materialized. Turkey, oyster stuffing, potatoes, green bean casserole, and there, hidden in the corner hidden in a warming dish, her creamed onions. More food than could ever be consumed. As we all waited our turn, her husband made her plate with tiny flecks of turkey, a strand or two of green bean, a half teaspoon of sweet and mashed potatoes, and a single creamed onion.

Her husband said the grace. “Bless us, o’ Lord, and these thy gifts which we are about to receive…” I stared at our plates and then at hers. The tiny onion, there alone. Her eyes closed and soft hands folded. I wondered what she was thinking. What does one think at their last Thanksgiving? I hated myself for wondering.

Really, it didn’t matter. It was about the here and now that mattered. “Life is what happens when you’re making other plans,” my wife still reminds me. And sure enough, despite a week and a half of food intolerance and dehydration, she ate it all.

Sunday, November 18, 2012

One was a silent war hero from the French Resistance, the other his doctor.

It was a chance encounter. He, supporting his wife as she checked in to the orthopedic clinic, the other, there himself for the first time as patient. For each, as life, it was unexpected.

They sat smiling, reflecting on the irony of it all.

Their story together, while brief at first, was rich. On a trip back to his homeland of France, he had brought down a 747 single-handedly as his defibrillator fired repeatedly. The event both humbled and embarrassed his doctor whose hubris had assured him of the effectiveness of a prior ablation, only to awaken to the epiphany that arrhythmias, like life, are difficult to predict. An AV junction ablation would be required to quell another unexpected arrhythmic onslaught. Both realized they were doing the best they could at the time. Neither were in control. But both had prevailed together. And through their long history together, more stories were told - secret, personal stories - as they developed a deep sense of admiration and appreciation for the other. But the stories were always told on the doctors' turf.

Until now.

There they were again: younger doctor joining the war hero once more as equals.

Fighting the fight on the same field now. Quietly sitting. Staring. Smiling.

Friday, November 16, 2012

Better yet, imagine doctors using cellphones to help care for patients.

It's a beautiful thing, really: efficient, timely, graphical. Doctors, like most people, love the convenience and utility of their smartphones.

But doctors aren't like normal people. We are carefully regulated. We must abide by health care privacy rules and so, too, must the hospitals where we work. So communications about work, be it text messaging, e-mail, SMS messaging - all must be HIPAA compliant.

But an interesting collision of doctor's privacy rights and patient's privacy rights can occur in our new world of mobile health care computing, thanks to a kill switch present inside Apple's iPhone and cloud computing, especially if doctors were to use an EMR app on their cell phone.

Doctors are well advised to understand how their personal smartphone and its information could be affected by corporate and patient security concerns.

Bzzzzaaaap.

Caveat emptor. Not only might your work place data disappear, but also your personal data, too.

Hearts and their arrhythmias are everywhere, and no where more than the news this week:

Jim Harbaugh, the NFL's reigning Coach of the Year and the face of the 49ers' resurgent franchise, had what the team termed a "minor procedure" performed at Stanford Hospital on Thursday - my bet: cardioversion.

5-hour energy drinks under federal investigation for possible proarrhythmia - reporters decide to test the theory on one of their own: "In an unscientific test at Florida Hospital Tampa’s Pepin Heart Institute, we had photographer Taylor Vinson drink one 5-hour Energy drink..."

Tuesday, November 13, 2012

It's hard to believe, but seven years ago this day, I wrote this blog's first entry.

It has been interesting for me to reflect on what I've written here. Over 3100 posts - some good, some not-so-good - reside here. Some day they will be succumb to spam bots and the electronic ether, never to be seen again. No matter.

This blog has evolved from a marketing mission for my t-shirt website to a place for creative reflection about the decline of my father's health and his eventual death, to an even more recent reflection of my perception of health care's effects on doctors and nurses. It has been silly at times, but remarkably heartfelt at others. It has covered wide range of topics - some based on news stories, others based on one guy's life experiences. I have nurtured it, worshiped it, and disliked it at different times in its relatively short career. But I realize now what it's been for me most: my inexpensive therapist.

Here I can get lost in nuance and subtlety. Here I can describe my joys and frustrations with health care and our profession. Here I can laugh at the ridiculous, the mundane, the silly. Here I can mourn a colleague, an experience, or family member's death. This blog has connected me with people I would never have met while being one of the more isolated and personal activities I pursue.

New content for this blog, at least like I want it to be, is getting harder for me to come by. Perhaps this is why I find I'm writing less and less. Perhaps it's because what I want to say, I've said before. Perhaps it's because I don't always want to sound like the sky is falling in health care, but there remains so much to be concerned about in our new era of health care going forward. Feel-good story lines that ignore reality in favor of an agenda are dangerous. Increasingly, doctors are having a hard time behaving as Walmart greeters, ever pleasant and ever smiling as we are the manipulated tools of the trade. I'm not a big fan of fiction.

My writing, like all of us as we mature, is changing. I find now that I like to discuss the psychology and physiology of what's happening to doctors in our new, changing health care world. I find I like to discuss the the story-behind-the-story or the Bigger Picture more that my take on a news story or study result. (Believe me, it's easy to criticise studies yet far harder to perform them). And yes, I still enjoy teaching about an EKG finding or two. Still, much of what gets written here has felt like I'm fencing at windmills as forces far more influential in health care move forward. As such, my idealistic goal of influence has adapted to a goal of realism. Time is real. So are the kids. So are work demands. As a result, blogging suffers.

Reality.

Life's priorities change. My wife, kids, family, friends, dog and workplace will forever supersede this space. Life is incredibly short. Yet I find I still cherish my precious time behind the keyboard when I can take a moment to reflect on issues that concern me or excite me about health care and this thing called being a doctor. Yes, it is harder now. But this therapeutic blog continues to teach me one thing I never imagined as a math, science, and engineering nerd who later became physician:

Saturday, November 10, 2012

Mouse over and click to choose a shirt

Conventional wisdom says if illness has to happen at all, illness should be overcome, fixed, and left behind. We have few role models and few realistic stories about living with a less-than-perfect body, or less-than-perfect health. How we choose to deal with the cards that life gives us is what our t-shirt site, MedTees.com is all about.

This year, we will be donating 100% of all proceeds we have received from the sales of shirts from 2012 to the various charities that each shirt design supports. A partial list of charities we support can be found here.

Thursday, November 08, 2012

I have used the Electronic Medical Record (specifically EPIC) since 2004. I have grown accustomed to its nuances, benefits and quirks. There are parts about it I really like. There are parts of it I'd like to do without but accept that they are necessary evils in our current health care climate. I know that there will always be parts of any modified computer system that will suffer growing pains. For any new and adapting technology this is understandable.

But there is a little-appreciated issue that I see brewing: doctors (and maybe even patients) are quietly being buried by electronic information overload. As a result, I believe doctors are being placed at an increased liability risk.

Let me explain.

In the past era of medicine, nothing happened without a doctor's order. Nothing. If you wanted a medication, lab test, invasive procedure, opportunity to participate in rehab classes - anything - you needed a doctor's order. For the years of paper records and independent doctors offices, this work flow assured that doctors (1) knew what was happening with their patients, (2) saw their patients, (3) prescribed the proper therapy, and (4) assumed the risk for the intervention or treatment prescribed. Information proceeded in a logical linear fashion and the doctor was always at the head of the information line.

But we are no longer in the old days in medicine. We are in the era of near-instantaneous information flow, multi-directional electronic communication, and geographically disparate order entry by "caregivers," (think nurses, nurse practitioners, advanced practice nurses, clinic operators, registrars, etc.) who help us take messages, continue care, and order things. In this electronic process, messages are no longer passed from just one individual to another, but rather are passed to two, three, four, or more individuals simultaneously from any one of several different clinical locations - some of which might be many miles apart. There is an incredible amplifying effect of all of these messages, orders, and notifications -- so much so that even the most tech-savvy doctors are struggling to keep up. In fact, it is not uncommon for a doctor these days to work for two hours on a procedure and return to the computer to find twenty or thirty new notifications, e-mails, or orders have been deposited there. Head back in for the next case and then another thirty items appear. Pretty soon, it's an avalanche of items. Worse: doctors must click on each one of these notifications individually to "verify" he or she has looked at each and every single one.

Doctors understand that the reason we have to click on all these orders is because (a) no one gets paid in our system unless a doctor orders whatever-it-is and (b) someone has to be the fall guy if there's a problem with a nurse, medical assistant, or lab technician that "orders" something on behalf of the physician. There is even a trend to auto-order things (like a pneumovax vaccine, for instance) that assure the hospital maintains excellent public reporting metrics whether the doctor ordered them or not with the order later appearing in our inbox to be clicked.

But worst of all are the silent notifications sent from fellow physician colleagues buried amongst the other notifications. They tell of an important story, one that needs fairly urgent attention, but because people no longer pick up the phone, are not immediately noticed or highlighted. It's like a landmine sitting in a doctor's inbox waiting to be stumbled upon.

* Click* *Click* *Click* * Click* *Click* *Boom*

With all these people and devices ordering and sending, the limited number of doctors out there are being bombarded from multiple directions. It is getting harder to keep up these days. Orders and notices come to us on names we don't recognize or have been long forgotten. (Computers don't forget that you saw the patient eight years ago). And once an order is placed and acted upon without our knowledge these days, we click on the order to clear our notices and thereby assume all the legal risk for the care.

The legal buck still ultimately stops with us.

Doctors need to speak up about this problem. We are not in the old days any longer. We are in the fast-paced, electronic medical record era where things happen (literally) at the speed of light. We need the electronic medical record companies, payors, hospitals and legal community to come together to help us find a solution to this current infomation overload crisis that maintains patient safety and improves efficiencies while limiting legal risks to the doctors who are doing their very best just to keep up.

Monday, November 05, 2012

Recovery Mode is what every doctor experiences after a rough night on call, a stressful case, a phrenetic day or week of constant clinical ups and downs.

No matter what the cause, it inevitably takes a while to recover.

And as I get older, I reflect on how Recovery Mode has impacted me and my family more. Perhaps it is the years of entering and exiting Recovery Mode. Or maybe, it's because with age, it's harder to rebound, I'm not sure. But usually, there is relief that you've made it through another test of your endurance, both physically and emotionally when you leave Recovery Mode and reenter a more normal work pattern.

Recovery Mode should not be confused with doctor burnout. Rather, Recovery Mode it is a natural and expected consequence of our job that involves sleep deprivation, tough decisions, and the high levels of attention to more and more details required of doctors that are often proscribed by others. Inevitably, it takes time to recover to baseline after an unsual amount of these "normal" events.

But the effects of Recovery Mode are real. I know it. The kids know it. So does my wife.

The office computer was used to be Skynet's reach, but it quickly expanded to the home computer and the cell phone, provided you're willing to have the cell phone's memory swiped clean if you leave Skynet's grasp. Personal schedules, too, have fallen victim to Skynet as everyone's whereabouts are tracked for all to see in the name of staffing and operating efficiency.

And this week, "personalized medicine" moved a step closer as the complete DNA material of more than 1,000 people from 14 population groups in Europe, Africa, East Asia and the Americas were sequenced so they may serve as a standard reference against which doctors could one day compare a patient's genome profile, even during a routine checkup.

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About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.